MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	450952-NL
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check the customer found a pinhole in the anesthesia circuit.No patient injury was reported.
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record (dhr) review could not be completed.No product sample was received; therefore, no visual and functional testing could be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2jo kudaru, kawaharamachidori,; minneapolis, MN 55442
• MDR Report Key: 15410938
• Report Number: 3012307300-2022-18950
• Device Sequence Number: 5653047
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 450952-NL
• Device Catalogue Number: 450952-NL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown